FDA Warns of Transvaginal Mesh Side Effects
The United States Food & Drug Administration (FDA) issued a warning letter to American Medical Systems (AMS), a subsidiary of Endo Health Solutions, Inc. and a manufacturer of transvaginal mesh, related to problems involving risk analysis and process validation procedures. The letter was disclosed in a filing with the U.S. Securities and Exchange Commission (SEC) by Endo Health Solutions, Inc. on April 16, 2014. It addressed various shortcomings of the facility whose products have resulted in transvaginal mesh side effects nationwide.
The FDA’s letter was sent on April 10th in relation to a February inspection of a Minnetonka, Minnesota American Medical Systems manufacturing plant. The SEC filing also includes details from AMS on their plan of action for correction of the named problems. AMS will be subject to a follow-up inspection to ensure it complied with the necessary corrections. The letter went on to state that the solutions proposed by AMS were adequate, but they needed to accelerate their progress.
Approximately 17,000 lawsuits have been filed for women who have allegedly suffered from AMS transvaginal mesh side effects. Transvaginal mesh side effects can become lifelong hindrances for women. TVMs are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Traditional mesh treatment would see the product installed through small cuts in the woman’s abdomen. The transvaginal implantation procedure was meant to lower the impact and improve recovery times for the woman.
Transvaginal Mesh Side Effects
Instead, women were subject to a wide range of transvaginal mesh side effects. These include extreme pain in the pelvis, abdomen, or down the legs, infection, bleeding, painful intercourse, punctured organs, and erosion of the mesh. The transvaginal mesh side effects are often just as—if not more—severe than the problems they were meant to correct.
The Resulting Litigation
Transvaginal mesh side effects have become a significant source of lawsuits levied against TVM manufacturers. Lawsuits allege that the defective product was not given the appropriate amount of testing before being approved by the FDA. This is a matter of public record. Transvaginal mesh was approved by the FDA under their 510 (k) clause. Essentially, the manufacturer only needs to prove that its product serves a nearly identical function to products already on the market. The manufacturers and FDA failed to account for where the mesh was being installed and how. The soft vaginal tissue had a much different reaction than other soft tissues.
Victims claim that manufacturers engaged in willful deception about the ratio of the benefits and risks of the product. This includes alleged deception on the part of doctors that were prescribing the product. Nearly 2,000,000 women have been implated with a TVM for treating problems like POP and SUI. The first bellwether trial involving American Medical Systems transvaginal mesh started June 2nd, 2014.
Seeking Legal Counsel
Any woman who believes she is the victim of transvaginal mesh side effects should call TVM Info Center today. Deadlines come into play once legal actions have been rolled into a MultiDistrict Litigation (MDL). The deadlines for filing are dependent on individual factors, such as the date of installation and the company involved. Call today so we can answer your questions and address your concerns. TVM Info Center can provide a free, no obligation consultation about your claim. Should there be actionable grounds to pursue it, we can connect you with an affiliated attorney who is experienced with legal action surrounding transvaginal mesh side effects. Your pain and suffering should not go unanswered if you were negatively impacted by transvaginal mesh. Contact the TVM Info Center today for your free consultation.